MAUDE Adverse Event Report: COOK INC ATB ADVANCE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Model Number	N/A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, or unavailable.(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.Blank fields on this form indicate the information is unknown, or unavailable.
Event or Problem Description
An atb advance balloon catheter was used while treating stenosis in an a/v fistula in the upper arm.It was reported, the balloon burst at 12 atm.Another balloon was used to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), specifications, quality control, and visual inspection of the returned device was conducted during the investigation.One used atb advance balloon catheter was returned for evaluation and examined.An attempt was made to inflate the balloon and leakage was detected.The balloon is ruptured longitudinally.No non-conformities were noted on the surface of the catheter.The length of the catheter measured within specifications.The length of the balloon measured within specifications.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows one nonconforming event that could contribute to this failure mode.There were no other reported complaints for this lot number.Numerous design verification and validation activities have been performed to ensure that this device meets design requirements.Based on the information provided, examination of the returned product, and the results of our investigation; a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• Brand Name: ATB ADVANCE BALLOON CATHETER
• Common Device Name: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6877195
• Report Number: 1820334-2017-03196
• Device Sequence Number: 19128214
• Product Code: DQY
• UDI-Device Identifier: 00827002269040
• UDI-Public: (01)00827002269040(17)190719(10)8078471
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K033875
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ATB5-35-80-8-4.0
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/13/2017
• Supplement Date Received by Manufacturer: 10/19/2017
• Initial Report FDA Received Date: 09/19/2017
• Supplement Report FDA Received Date: 11/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1